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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 034 Date of Entry 01/30/2014 
FR Recognition Number 6-253
Standard
ISO  10535 Second edition 2006-12-15
Hoists for the transfer of disabled persons - Requirements and test methods
Scope/Abstract
ISO 10535:2006 specifies requirements and test methods only for hoists and body-support units intended for the transfer of disabled persons as classified in ISO 9999:2002:
- 12 36 03 Mobile hoists with sling seats
- 12 36 04 Standing mobile hoists
- 12 36 06 Mobile hoists with solid seats
- 12 36 09 Hoist trolleys
- 12 36 12 Stationary hoists fixed to the wall/walls, floor and/or ceiling
- 12 36 15 Stationary hoists fixed to, mounted in or on another product
- 12 36 18 Stationary free-standing hoists
- 12 36 21 Body-support units for hoists
The requirements of ISO 10535:2006 are formulated with regard to the needs of both the disabled persons being hoisted and the attendant using the hoist.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Transition Period
FDA recognition of ISO 10535 Second edition 2006-12-15 [Rec# 6-253] will be superseded by recognition of ISO 10535 Third edition 2021-10 [Rec# 6-486]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 6-253] until July 6, 2025. After this transition period, declarations of conformity to [Rec# 6-253] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§880.5500 Lift, Patient, Ac-Powered Class 2 FNG
§880.5510 Lift, Patient, Non-Ac-Powered Class 1 FSA
Relevant FDA Guidance and/or Supportive Publications*
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contacts
 Matthew Schwerin
  FDA/OC/CDRH/OSEL/DAM/
  301-563-9114
  matthew.schwerin@fda.hhs.gov
 Alan Stevens
  FDA/OC/CDRH/OPEQ/OHTIII/DHTIIIC/
  301-796-6294
  Alan.Stevens@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
General Plastic Surgery/General Hospital
*These are provided as examples and others may be applicable.
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